Imaging-Guided Vessel Sizing in the Tibial Arteries

Completed

• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Interventions: Diagnostic Test: Digital Subtraction Angiography

• Registration Number: NCT04748965
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

Detailed Description

This is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. The evaluation of OCT is primarily to: (a) establish feasibility and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. Operator-determined sizing will be compared against University Hospitals Core Imaging Laboratory assessment of OCT, IVUS (when applicable), and quantitative vessel analysis (QVA).

Subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. Wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. Wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.

Study Timeline

• Study First Submitted: 2020-12-12
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-08-16
• Primary Completion: 2024-06-09
• Study Completion: 2024-06-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age >18
• Patients with presence of Rutherford IV-VI
• Presence of ≥1 tibial artery involvement requiring endovascular treatment

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Exclusion Criteria

• Patients who do not have tibial disease appropriate for intervention
• Estimated glomerular filtration rate <30 mL/min not on hemodialysis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tibial Vessel Involvement in Patients with peripheral artery disease and CLI	Digital Subtraction Angiography	The primary goal is to establish a protocol for performing optimal OCT in below-the-knee vessels. OCT images will be analyzed for lesion characteristics, lesion sizing pre- and post-intervention. This will be analyzed against QVA and IVUS (latter if applicable).

Primary Outcome Measures

Name	Time	Method
Standardized Technique for OCT Use in the Lower Limb	12 months	To develop a protocolized, reproducible technique to maximize the Clear Image Length (CIL) on 75 mm pullbacks using 100% contrast in the tibial arteries. The goal is to compare intravascular ultrasound (IVUS) and optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

Secondary Outcome Measures

Name	Time	Method
Vessel Characteristics: Minimal Lumen Area	12 months	minimal lumen area (mm\^2)
Vessel Characteristics: Reference Vessel Diameter	12 months	reference vessel diameter (mm)
Plaque Characteristics: Calcium Depth	12 months	depth of calcium (micron)
Attenuation	12 months	Measurement of attenuation coefficient (μ OCT) to quantify the strength of interaction of light and tissue
Vessel Characteristics Following Intervention: Plaque Modification	12 months	Reduction in calcium depth (%) if atherectomy is performed
Vessel Characteristics Following Intervention: Dissections	12 months	Qualitative description of dissections seen on post-intervention imaging
Comparison of Percent Contrast	12 months	CIL in 100% contrast versus 50% contrast/heparinized saline mixture
Vessel Characteristics: Percentage Stenosis	12 months	percentage stenosis (%) on pre-intervention imaging
Vessel Characteristics Following Intervention: Luminal Gain	12 months	Post-intervention luminal gain (%), plaque modification, and dissections
Vessel Characteristics: Reference Vessel Area	12 months	reference vessel area (mm\^2)
Plaque Characteristics: Morphology	12 months	Percentage composition of calcium, fibrous, or lipid plaque (%)
Plaque Characteristics: Calcium Arc	12 months	Calcium arc (degree)
Plaque Characteristics: Fibrous cap	12 months	depth of fibrous cap (micron)

Trial Locations

Locations (3)

University Hospitals Ahuja Medical Center; 🇺🇸 Beachwood, Ohio, United States

University Hospitals Parma Medical Center; 🇺🇸 Parma, Ohio, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States